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A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants

NCT04234672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-06-30

Study results available
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Summary

The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) \[14C\]TAK-831 in Period 2.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TAK-831 Oral Tablet

TAK-831 tablet.

DRUG

[14C]TAK-831 IV Infusion

\[14C\]TAK-831 IV infusion.

DRUG

[14C]TAK-831 Oral Suspension

\[14C\]TAK-831 oral suspension.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Neurocrine Biosciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2020-04-04
Completion
2020-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234672 on ClinicalTrials.gov